Clinical and hemodynamic outcomes of "all-comers" undergoing transapical aortic valve implantation: Results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA)

Augusto D'Onofrio, Paolo Rubino, Melissa Fusari, Loris Salvador, Francesco Musumeci, Mauro Rinaldi, Ettore O. Vitali, Mattia Glauber, Roberto Di Bartolomeo, Ottavio R. Alfieri, Elvio Polesel, Marco Aiello, Riccardo Casabona, Ugolino Livi, Claudio Grossi, Mauro Cassese, Aniello Pappalardo, Tiziano Gherli, Guglielmo Stefanelli, Giuseppe G. FaggianGino Gerosa

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Abstract

Objective: The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Methods: From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24% ± 16% and 11% ± 4%, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, <20 cases) and learning curve (first 50% cases vs second 50% cases of each center). Results: All-cause overall mortality was 8.3% (42 patients). Device success was 99% (500/504 patients). Intraoperative severe complications occurred in 24 (4.8%) patients. Overall 2-year survival was 71.5% ± 6.2%. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm2. These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95% confidence intervals [CI], 1.28-15.40; P = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95% CI, 1.02-3.29; P = .04); creatinine concentration greater than 200 μmol/L (OR, 2.56; 95% CI, 1.07-6.15; P = .03), and intraoperative complications (OR, 5.80; 95% CI, 2.68-12.55; P <.001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50% of cases. Conclusions: TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival.

Original languageEnglish
Pages (from-to)768-775
Number of pages8
JournalJournal of Thoracic and Cardiovascular Surgery
Volume142
Issue number4
DOIs
Publication statusPublished - Oct 2011

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Aortic Valve
Registries
Hemodynamics
Intraoperative Complications
Odds Ratio
Confidence Intervals
Learning Curve
Survival
Mortality
Creatinine
Equipment and Supplies

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery
  • Pulmonary and Respiratory Medicine

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Clinical and hemodynamic outcomes of "all-comers" undergoing transapical aortic valve implantation : Results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). / D'Onofrio, Augusto; Rubino, Paolo; Fusari, Melissa; Salvador, Loris; Musumeci, Francesco; Rinaldi, Mauro; Vitali, Ettore O.; Glauber, Mattia; Di Bartolomeo, Roberto; Alfieri, Ottavio R.; Polesel, Elvio; Aiello, Marco; Casabona, Riccardo; Livi, Ugolino; Grossi, Claudio; Cassese, Mauro; Pappalardo, Aniello; Gherli, Tiziano; Stefanelli, Guglielmo; Faggian, Giuseppe G.; Gerosa, Gino.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 142, No. 4, 10.2011, p. 768-775.

Research output: Contribution to journalArticle

D'Onofrio, A, Rubino, P, Fusari, M, Salvador, L, Musumeci, F, Rinaldi, M, Vitali, EO, Glauber, M, Di Bartolomeo, R, Alfieri, OR, Polesel, E, Aiello, M, Casabona, R, Livi, U, Grossi, C, Cassese, M, Pappalardo, A, Gherli, T, Stefanelli, G, Faggian, GG & Gerosa, G 2011, 'Clinical and hemodynamic outcomes of "all-comers" undergoing transapical aortic valve implantation: Results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA)', Journal of Thoracic and Cardiovascular Surgery, vol. 142, no. 4, pp. 768-775. https://doi.org/10.1016/j.jtcvs.2011.06.026
D'Onofrio, Augusto ; Rubino, Paolo ; Fusari, Melissa ; Salvador, Loris ; Musumeci, Francesco ; Rinaldi, Mauro ; Vitali, Ettore O. ; Glauber, Mattia ; Di Bartolomeo, Roberto ; Alfieri, Ottavio R. ; Polesel, Elvio ; Aiello, Marco ; Casabona, Riccardo ; Livi, Ugolino ; Grossi, Claudio ; Cassese, Mauro ; Pappalardo, Aniello ; Gherli, Tiziano ; Stefanelli, Guglielmo ; Faggian, Giuseppe G. ; Gerosa, Gino. / Clinical and hemodynamic outcomes of "all-comers" undergoing transapical aortic valve implantation : Results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). In: Journal of Thoracic and Cardiovascular Surgery. 2011 ; Vol. 142, No. 4. pp. 768-775.
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abstract = "Objective: The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Methods: From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24{\%} ± 16{\%} and 11{\%} ± 4{\%}, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, <20 cases) and learning curve (first 50{\%} cases vs second 50{\%} cases of each center). Results: All-cause overall mortality was 8.3{\%} (42 patients). Device success was 99{\%} (500/504 patients). Intraoperative severe complications occurred in 24 (4.8{\%}) patients. Overall 2-year survival was 71.5{\%} ± 6.2{\%}. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm2. These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95{\%} confidence intervals [CI], 1.28-15.40; P = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95{\%} CI, 1.02-3.29; P = .04); creatinine concentration greater than 200 μmol/L (OR, 2.56; 95{\%} CI, 1.07-6.15; P = .03), and intraoperative complications (OR, 5.80; 95{\%} CI, 2.68-12.55; P <.001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50{\%} of cases. Conclusions: TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival.",
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T1 - Clinical and hemodynamic outcomes of "all-comers" undergoing transapical aortic valve implantation

T2 - Results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA)

AU - D'Onofrio, Augusto

AU - Rubino, Paolo

AU - Fusari, Melissa

AU - Salvador, Loris

AU - Musumeci, Francesco

AU - Rinaldi, Mauro

AU - Vitali, Ettore O.

AU - Glauber, Mattia

AU - Di Bartolomeo, Roberto

AU - Alfieri, Ottavio R.

AU - Polesel, Elvio

AU - Aiello, Marco

AU - Casabona, Riccardo

AU - Livi, Ugolino

AU - Grossi, Claudio

AU - Cassese, Mauro

AU - Pappalardo, Aniello

AU - Gherli, Tiziano

AU - Stefanelli, Guglielmo

AU - Faggian, Giuseppe G.

AU - Gerosa, Gino

PY - 2011/10

Y1 - 2011/10

N2 - Objective: The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Methods: From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24% ± 16% and 11% ± 4%, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, <20 cases) and learning curve (first 50% cases vs second 50% cases of each center). Results: All-cause overall mortality was 8.3% (42 patients). Device success was 99% (500/504 patients). Intraoperative severe complications occurred in 24 (4.8%) patients. Overall 2-year survival was 71.5% ± 6.2%. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm2. These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95% confidence intervals [CI], 1.28-15.40; P = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95% CI, 1.02-3.29; P = .04); creatinine concentration greater than 200 μmol/L (OR, 2.56; 95% CI, 1.07-6.15; P = .03), and intraoperative complications (OR, 5.80; 95% CI, 2.68-12.55; P <.001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50% of cases. Conclusions: TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival.

AB - Objective: The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Methods: From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24% ± 16% and 11% ± 4%, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, <20 cases) and learning curve (first 50% cases vs second 50% cases of each center). Results: All-cause overall mortality was 8.3% (42 patients). Device success was 99% (500/504 patients). Intraoperative severe complications occurred in 24 (4.8%) patients. Overall 2-year survival was 71.5% ± 6.2%. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm2. These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95% confidence intervals [CI], 1.28-15.40; P = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95% CI, 1.02-3.29; P = .04); creatinine concentration greater than 200 μmol/L (OR, 2.56; 95% CI, 1.07-6.15; P = .03), and intraoperative complications (OR, 5.80; 95% CI, 2.68-12.55; P <.001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50% of cases. Conclusions: TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival.

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